Corticosteroids to Reduce Inflammation in Severe Pancreatitis: A Randomized, Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Severity of Illness Measure
研究概览
简要总结
This research is being done to determine if the administration of a short course of intravenous hydrocortisone, an anti-inflammatory medication, to patients with severe acute pancreatitis will improve their clinical outcomes and decrease the length of hospitalization. We think that because inflammation in the body drives the progression of pancreatitis, giving a short course of intravenous hydrocortisone may mitigate disease progression and improve clinical outcomes in patients with severe acute pancreatitis.
详细描述
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous hydrocortisone on clinical outcomes in patients with severe acute pancreatitis. The interventional drug is Hydrocortisone (100 mg of hydrocortisone in 50 milliliters of saline solution). The placebo is saline and is identical in appearance and volume to the interventional drug. Study drug will be administered intravenously every 8 hours for 72 hours as per standard clinical procedures by nursing staff. The patient's sequential organ failure assessment score (SOFA) will be assessed for changes over time. Blood will be drawn at several time points to assess biomarkers over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The hydrocortisone and placebo solutions are identical in appearance/volume. Only the research pharmacist, (not a member of either the research or clinical teams) will have access to the treatment allocations to ensure blinding of the investigators and clinical staff.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years)
- •Acute pancreatitis as defined by a clinical diagnosis of pancreatitis and a lipase level ≥3x the upper limit of normal.
- •Admission or planned admission to an intensive care unit
- •SOFA disease severity score ≥3 (or at least 3 points above a known baseline)
排除标准
- •Known diagnosis of autoimmune pancreatitis
- •Existing clinical indication for corticosteroids at a dose >5mg of oral prednisone daily (or equivalent)
- •Contraindication to receiving corticosteroids
- •Protected populations (prisoners)
研究组 & 干预措施
Hydrocortisone
Patients in this arm will be administered 100 mg of hydrocortisone in 50 milliliters of saline solution by nursing staff every 8 hours for 72 hours as per standard clinical procedures (9 administrations)
干预措施: Hydrocortisone (Drug)
Placebo
Patients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations)
干预措施: Placebo (Drug)
结局指标
主要结局
Severity of Illness Measure
时间窗: Enrollment to 72 hours
Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours
次要结局
- Severity of Illness Measure Stratified By Predicted Survival (Physician Opinion)(Enrollment to 72 hours)
- Severity of Illness Measure Stratified By Bedside Index of Severity in Acute Pancreatitis (BISAP) score(Enrollment to 72 hours)
- In-hospital mortality(Enrollment to 90 days [truncated at 90 days])
- Alive and Hospital free days(Enrollment to 28 days [truncated at 28 days])
- Respiratory Failure Measure(Enrollment to 28 days [truncated at 28 days])
- Long-term Functional/Quality of Life Measure(90 days after Enrollment)
- Alive and Ventilator Free Days(Enrollment to 28 days [truncated at 28 days])
- 28-day mortality(Enrollment to 28 days [truncated at 28 days])
- 90-day mortality(Enrollment to 90 days [truncated at 90 days])
研究者
Michael Donnino
Professor of Emergency Medicine
Beth Israel Deaconess Medical Center